A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease

Sponsor
Peter Rossing
Study ID
NCT07239570
Phase
PHASE4
Status
Recruiting
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Conditions

  • Chronic Kidney Disease(CKD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg daily.
  • Semaglutide — DRUG
    Semaglutide injection once weekly. Will be titrated every 4 weeks to the highest tolerable dose according to standard guidelines, aiming at 1 mg once weekly.
  • Finerenone — DRUG
    Finerenone 10-20 mg daily.

Study Details

Over 800 million people worldwide suffer from chronic kidney disease (CKD), which is associated with a high individual disease burden for those affected, multiple secondary diseases, frequent doctor contacts, and hospitalizations, but also outstanding costs for the health system and the solidarity community. Appropriate interventions are essential to prevent the development and progression of CKD. In the past decade, great progress has been made in the search for drugs that can slow the progression of CKD. Sodium-glucose co-transporter 2 inhibitors, the non-steroidal mineralocorticoid receptor antagonist, finerenone, and the glucagon-like peptide-1 receptor agonist, semaglutide, have demonstrated albuminuria-lowering effects and kidney protection in people with CKD. Although these new pharmacological approaches show great promise, it is unclear how to optimally sequence and combine these therapies. In addition, the therapies are often not implemented due to treatment inertia and fear of adverse effects. This study aims to address this knowledge gap by utilizing a biomarker-guided treatment approach to reduce the decline in kidney function. The aim of the CKD-bioMatch study is to evaluate the efficacy of a biomarker-targeted treatment approach versus standard of care in people with CKD and albuminuria. We hypothesize that a biomarker-targeted treatment approach is superior to standard of care at reducing estimated glomerular filtration rate (eGFR) decline in people with CKD.

Key Dates

Start date
Jun 20, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard of care
    Participants in the standard of care group will receive treatment following the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines.
  • Experimental: Biomarker-targeted treatment
    In the treatment arm, the participants will receive stepwise treatment with one or more study drugs. The choice, order, and number of treatments introduced will be based on the participant's characteristics/risk profile and the response on UACR and UEGF.

Primary Outcome Measure

Chronic eGFR slope [ Time Frame: From week 26 to 104 ]

Central Contacts

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